Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name dura substitute
510(k) Number K131792
Device Name SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY
Applicant
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact HEATHER GUERIN
Correspondent
SYNTHES INC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact HEATHER GUERIN
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received06/18/2013
Decision Date 12/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-